Women left blinded by clinical trial that never was

Three US women have been left blind following an experimental treatment that they believed was part of a drug trial.

According to The New England Journal of Medicine, the women suffered complications including vision loss, detached retinas and bleeding within a week of receiving the treatment.

Two of the patients learned of the study in 2015 on clinicaltrials.gov.In fact, the details are still there, under the title “Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration.” Crucially though, it is now accompanied by the comment “This study has been withdrawn prior to enrolment.”

So how did they end up being treated in a study that had supposedly never reached the recruitment stage?

The patients in question had each paid over £4,000 to receive the treatment – and none of the consent forms and other paperwork actually stated that the women were involved in a trial, according to Thomas Albini, associate professor of clinical ophthalmology at the University of Miami. He was in charge of the team trying to help the women following the botched procedure and described the procedure as “off-the chart dangerous.”

Not even the basics of good clinical practice were followed. For some reason, the experimenters compounded the damage by treating both eye at once. Most experimental eye procedures are tested on one eye first so that if something goes catastrophically wrong the patient is still able to see with the other eye.

The trial was not preceded by laboratory experiments there was no comparison between treated patients and any “control group.”

In Professor Albini’s view, “there’s a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer.”

“We expect health care providers to take every precaution to ensure patient safety, but this definitely shows that the lack of oversight can lead to bad players and bad outcomes. It’s alarming.”